MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA LRS PLATELET PLASMA SET

Catalog Number 12400

Device Problems Use of Device Problem (1670); Volume Accuracy Problem (1675)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, total acda used was 375 ml, 199 ml to the donor.The correct solutions were attached to the correct lines.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that at the end of a platelet collection, the total blood volume (tbv) shown on the machine was higher than the donor's starting tbv.Initial tbv: 5690 ml ending tbv: 8426 ml the donor did not have any citrate symptoms or reactions, and no medical intervention was needed during or after the procedure.Patient identifier is not available at this time.The disposable set is not available for return because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.10.Investigation: based on the donor receiving 199 ml ac, 5.69 l tbv and 54 minutes procedural time.The average ac infusion rate is as follows: 199 ml / 54 min / 5.69 ltbv = 0.65 ml/min/ltbv.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.10.Investigation: the run data file was reviewed for this event.Review of the run data file showed that the incorrect height and weight was entered from the beginning of the procedure.Entered donor information actual donor information gender male.Male height: 170, 184.Weight: 187, 8.7 calculated tbv: 8427, 5690.Hgb: 13.7 / 12.7, 13.3.Platelet precount: 370 / 394, 370, 15%.Tbv: 1.264, 854.The trima accel system requires the operator to confirm all donor vitals entered before prompting to connect the donor.The trima accel system requires confirmation if an entered height and weight combination is outside of the acceptable bmi range in mix-ups and general mis-entries.The total product volume collected = predicted platelet volume + predicted plasma volume ¿ volume of ac in platelet product ¿ volume of ac in plasma product 1038 ml = 750 ml + 460 ml ¿ 105 ml ¿ 67ml the calculated donor volume removed (1038 ml) equals 18.24% of the actual tbv (5690 ml), hence no hypovolemia was alleged.The machine configuration and the actual donor information was entered in the trima accel single run prediction tool.This verified the donor qualified for a platelet product of 9.0e11/750 ml and the minimum post platelet count was met.The average ac infusion rate (ml/min/l tbv) = (total ac to donor (ml))/(procedure time (min) calculated tbv of donor (ml)) during the collection, an average ac infusion rate of 0.44 ml/min/l tbv (= (199 ml)/(54.4 min 8.4 l )) was used.The adjusted ac infusion rate based on the actual donor information = 0.65 ml/min/l tbv (=(199 ml)/ (54.4 min 5.69 l tbv )).The trima accel system calculates the donor¿s total blood volume (tbv) based on the donor¿s gender, height and weight and determines the rate at which anticoagulant (ac) is delivered to the donor based on the tbv and length of the procedure.This feature is based on the knowledge that the absolute citrate accumulation (and the associated decrease in calcium) is in function of both the rate and the duration of ac infusion.Thus, higher citrate infusion rates can be tolerated in shorter procedures.The maximum ac infusion rate allowed on the system is in average of 1.2 ml ac/min/l tbv.Based on the ac infusion rate calculations for this procedure, the donor received 0.65 ml/min/l tbv, which is below the maximum ac infusion rate of 1.2 allowed on the system.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10 investigation : a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in b.5 and h.10.Investigation: the customer provided one picture of the optia gui screen that displayed the total blood volume was 8426ml during the return to the donor at the end of the procedure.Investigation is in process.A follow up report will be provided.

Event Description

Pursuant to eu personal data protection laws, the patient identifier is not available from the customer.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10 and corrected information in e.3 and h.10.Corrected investigation: the run data file (rdf) was analyzed for this event.Review of the run data file showed that the incorrect height and weight was entered from the beginning of the procedure.Table 1 gives an overview of the entered vs the actual donor information.Table 1: entered vs actual donor information entered donor information: actual donor information: gender: male: male height: 170 184 weight: 187 87 tbv 8427 5690 hgb 13.7 / 12.7 13.3 platelet precount 370 / 394 370 15% tbv 1.264 854 the spectra optia system requires the operator to confirm all donor vitals entered before prompting to connect the donor.The trima accel system requires confirmation if an entered height and weight combination is outside of the acceptable bmi range in mix-ups and general mis-entries.The total product volume collected = predicted platelet volume + predicted plasma volume ¿ volume of ac in platelet product ¿ volume of ac in plasma product 1038 ml = 750 ml + 460 ml ¿ 105 ml ¿ 67ml.The calculated donor volume removed (1038 ml) equals 18.24% of the actual tbv (5690 ml), hence no hypovolemia was alleged.The machine configuration and the actual donor information was entered in the trima accel single run prediction tool.This verified the donor qualified for a platelet product of 9.0e11/750 ml and the minimum post platelet count was met.The average ac infusion rate (ml/min/l tbv) = (total ac to donor (ml))/ (procedure time (min)*calculated tbv of donor (ml)) during the collection, an average ac infusion rate of 0.44 ml/min/l tbv (= (199 ml)/(54.4 min*8.4 l)) was used.The adjusted ac infusion rate based on the actual donor information = 0.65 ml/min/l tbv (=(199 ml)/(54.4 min * 5.69 l tbv)).The spectra optia system calculates the donor¿s total blood volume (tbv) based on the donor¿s gender, height and weight and determines the rate at which anticoagulant (ac) is delivered to the donor based on the tbv and length of the procedure.This feature is based on the knowledge that the absolute citrate accumulation (and the associated decrease in calcium) is in function of both the rate and the duration of ac infusion.Thus, higher citrate infusion rates can be tolerated in shorter procedures.The maximum ac infusion rate allowed on the system is in average of 1.2 ml ac/min/l tbv.Based on the ac infusion rate calculations for this procedure, the donor received 0.65 ml/min/l tbv, which is below the maximum ac infusion rate of 1.2 allowed on the system.Root cause: the root cause was due to the operator entering the incorrect donor height and weight at the beginning of the procedure.Correction: retraining offer was declined by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA LRS PLATELET PLASMA SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 10101172
• MDR Text Key: 196642556
• Report Number: 1722028-2020-00260
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 12400
• Device Lot Number: 1912023330
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACDA LOT # 19063027.
• Patient Outcome(s): Other
• Patient Age: 00055 YR
• Patient Weight: 87